Risankizumab for Psoriatic Arthritis

(KEEPsAKE2 Trial)

Not currently recruiting at 213 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Hypersensitivity to risankizumab, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 152

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of risankizumab (Skyrizi) for adults with psoriatic arthritis, a condition where the immune system attacks the joints and skin. Participants will receive either risankizumab or a placebo, a harmless substance used for comparison. Individuals with psoriatic arthritis symptoms for at least six months and frequent joint pain or swelling might be suitable candidates. The study also includes patients who did not respond well to other treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that risankizumab is generally safe for treating psoriatic diseases. In past studies, most patients tolerated the treatment well over time, with no new safety issues identified. The most common side effects were mild, including colds, headaches, and injection site reactions, which are usually not serious. This suggests that risankizumab is relatively safe for people with psoriatic arthritis. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for psoriatic arthritis?

Risankizumab is unique because it targets a specific part of the immune system involved in psoriatic arthritis, known as IL-23. Unlike standard treatments like TNF inhibitors, which block tumor necrosis factor, risankizumab focuses on this different pathway, potentially offering relief for patients who don't respond well to existing options. Additionally, it's administered by a convenient subcutaneous injection every 12 weeks after the initial doses, reducing the frequency of treatments compared to some current therapies. Researchers are excited about its targeted approach and the possibility of more personalized treatment for patients with psoriatic arthritis.

What evidence suggests that risankizumab might be an effective treatment for psoriatic arthritis?

Research has shown that risankizumab, which participants in this trial may receive, can help treat psoriatic arthritis (PsA). Many patients experienced a 20% improvement in symptoms like joint pain, stiffness, and swelling after 24 weeks. One study found that 57% of patients improved significantly compared to those taking a placebo. Additionally, 71.3% of participants saw a major reduction in skin symptoms. Risankizumab also reduced joint tenderness and swelling for up to 100 weeks. These findings suggest that risankizumab could be a promising treatment for PsA. ^{4 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with active psoriatic arthritis, having at least 5 tender and swollen joints, plaque psoriasis or nail changes. It's specifically for those who didn't respond well to or couldn't tolerate previous biologic therapies or conventional treatments.

Inclusion Criteria

I have been diagnosed with psoriatic arthritis for at least 6 months.

I have at least 5 tender and 5 swollen joints.

I have active plaque psoriasis with a plaque larger than 2 cm or nail changes.

Exclusion Criteria

You are allergic to risankizumab.

Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment Period 1

Randomized, double-blind, placebo-controlled period where participants receive either risankizumab or placebo

24 weeks

Visits at Week 0, Week 4, and Week 16

Treatment Period 2

Long-term period where all participants receive open-label risankizumab every 12 weeks

292 weeks

Dosing visits every 12 weeks until Week 316

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Telephone call 140 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Placebo for Risankizumab
• Risankizumab

Trial Overview

The study tests the safety and effectiveness of a drug called Risankizumab against a placebo in treating moderate to severe psoriatic arthritis. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

Group I: Risankizumab Experimental Treatment 2 Interventions

Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

Group II: Placebo Placebo Group 2 Interventions

Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Secukinumab demonstrated significant efficacy in treating psoriatic arthritis (PsA), showing robust improvements across all core domains, including joint counts, enthesitis, and skin severity, in a pooled analysis of 2049 patients from multiple phase III studies.

At a dosage of 300 mg, secukinumab led to complete resolution of swollen joints in 34.3% of patients and significant improvements in other symptoms, indicating its potential as an effective treatment option for various manifestations of PsA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients. Orbai, AM., McInnes, IB., Coates, LC., et al.[2021]

In a 24-week Phase 3 trial involving patients with psoriatic arthritis who had inadequate responses to previous treatments, risankizumab (RZB) significantly improved patient-reported outcomes, including pain, fatigue, and overall health-related quality of life compared to placebo.

Patients treated with RZB reported better scores in multiple health assessments, including the SF-36 and FACIT-Fatigue, indicating enhanced ability to perform daily activities and work, demonstrating its efficacy in managing symptoms of psoriatic arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved patient-reported outcomes in patients with psoriatic arthritis treated with risankizumab: analysis of the Phase 3 trial KEEPsAKE 2. Ostor, AJK., Soliman, AM., Papp, KA., et al.[2022]

Ixekizumab significantly improved disease activity and physical function in patients with active psoriatic arthritis (PsA) compared to placebo, regardless of whether patients were using concomitant conventional disease-modifying antirheumatic drugs (cDMARDs).

While treatment with ixekizumab was associated with a higher frequency of treatment-emergent adverse events compared to placebo, serious adverse events were not more common, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naïve patients with active psoriatic arthritis (PsA): results from SPIRIT-P1. Coates, LC., Kishimoto, M., Gottlieb, A., et al.[2022]

Risankizumab-rzaa (Skyrizi®) is an effective treatment for moderate-to-severe psoriasis, as demonstrated in four pivotal Phase III trials involving adult patients, showing both efficacy and safety.

The drug works by targeting interleukin-23p19 (IL-23p19), a key player in the inflammatory process of psoriasis, which helps reduce the symptoms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. Reddy, V., Yang, EJ., Myers, B., et al.[2020]

In the phase 3 KEEPsAKE 2 trial involving 444 patients with psoriatic arthritis, risankizumab significantly improved disease outcomes compared to placebo, with 51.3% of patients achieving at least a 20% improvement in their symptoms by week 24.

Risankizumab was well tolerated, with similar rates of serious adverse events (4.0% for risankizumab vs. 5.5% for placebo) and lower rates of serious infections compared to placebo, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Östör, A., Van den Bosch, F., Papp, K., et al.[2022]

Risankizumab, a monoclonal antibody targeting IL-23, received its first global approval in March 2019 in Japan for treating various forms of psoriasis, including psoriasis vulgaris and psoriatic arthritis.

The drug is currently approved in multiple regions, including the USA and EU, for moderate-to-severe plaque psoriasis and is undergoing further clinical trials for other conditions like Crohn's disease and ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. McKeage, K., Duggan, S.[2020]

Citations

1.

skyrizi.com

skyrizi.com/psoriatic-arthritis/skyrizi-results/efficacy

SKYRIZI® (risankizumab-rzaa) Results for Psoriatic Arthritis

The majority of patients felt a 20% improvement and significant relief in PsA symptoms, including joint pain, stiffness and swelling at 24 weeks.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10234194/

Efficacy and safety of risankizumab for active psoriatic ...

In the 24-week primary analysis, 51.3% of patients who received risankizumab achieved ≥20% improvement in ACR criteria (ACR20) compared with 26.5% of patients ...

3.

skyrizihcp.com

skyrizihcp.com/dermatology/psoriatic-arthritis-efficacy

SKYRIZI® Efficacy in Active Psoriatic Arthritis (PsA)

After 3 doses of SKYRIZI, 57% of patients achieved ACR20 response at week 24 VS placebo. In patients who achieved PASI 90 at Week 16, 88% maintained PASI 90 at ...

4.

rheumatologyadvisor.com

rheumatologyadvisor.com/news/risankizumab-shows-sustained-efficacy-across-grappa-psa-domains/

Risankizumab Shows Sustained Efficacy Across Psoriatic ...

In the KEEPsAKE 1 trial, 71.3% of participants achieved an at least 90% improvement in Psoriasis Area and Severity Index (PASI) scores and 72.7% ...

5.

rmdopen.bmj.com

rmdopen.bmj.com/content/11/3/e005522

Efficacy of risankizumab across GRAPPA domains in ...

Risankizumab demonstrated efficacy across all GRAPPA-defined domains through 100 weeks, including swollen and tender joint counts, enthesitis, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11393270/

Long-Term Safety of Risankizumab in Patients with ...

The results support the favourable safety profile of risankizumab for long-term treatment of psoriatic disease with no new safety concerns.

7.

skyrizihcp.com

skyrizihcp.com/dermatology/pso-psa-safety-profile

SAFETY PROFILE ESTABLISHED IN Ps AND PsA 1

Most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41028616/

Efficacy and Safety of Risankizumab for Active Psoriatic ...

Maintenance of ACR20 achievement in KS1 from week 52 to week 196 was observed for 71.0% of patients receiving continuous risankizumab and 72.7% ...

9.

academic.oup.com

academic.oup.com/rheumatology/article/62/6/2122/6772503

Efficacy and safety of risankizumab for active psoriatic arthritis ...

In the 24-week primary analysis, 51.3% of patients who received risankizumab achieved ≥20% improvement in ACR criteria (ACR20) compared with 26.5% of patients ...